Editor’s note:
Luye Pharma's innovative formulation, Goserelin Microspheres for Injection (Baituowei), was approved by China’s National Medical Products Administration (NMPA) on June 30, 2023. This product is the world’s first and only formulation of long-acting goserelin microspheres approved for launch. This project (LY01005) was officially initiated internally in February of 2010. The project team members worked together, overcame many difficulties, and marched side by side towards a common goal. This month, we are delighted to have 5 members from LY01005 project to share their stories of 13 years of dreams.
Q：Thank you and welcome for taking this interview. Let’s start with a brief introduction of yourself.
Yu: My name is Yu Pengfei. I’m a pharmacology researcher in the Group's R&D Non-Clinical Research Department, and is responsible for the study design of innovative drugs in terms of pharmacology, pharmacokinetics, toxicology, toxicokinetics, the process management of the study, the summarization and analysis of the results, as well as the writing of the filing materials. I joined Luye Pharma in September 2009, and joined LY01005 project team in the beginning of 2010 as PC head, this is also my first time to lead non-clinical work as the responsible person.
Li: My name is Li Chenglin from Analysis Department of Group R & D. I joined Luye in 2012 soon after graduation and is responsible for quality research of microspheres. I joined LY01005 in January of 2016, and was initially responsible for the analytical studies and quality studies of the project, and then served as the CMC leader of the project, responsible for dealing with related technical issues, reviewing NDA pharmacology information, and organizing responses to CRL during the review phase.
Liu: I am Liu Enyi. I joined Luye Pharma in December of 2016 and joined LY01005 in 2017. I've been in clinical research operations since before joining Luye.
Peng: My name is Peng Fang. I joined Luye in 2004 and started to work in drug registration since 2005. I joined LY01005 in 2013 and serve as the head of registration.
Geng: My name is Geng Yinyin. I have been with Luye since I graduated with my Master's degree in 2017 and joined the Project Management Department in 2020, during which time I held the position of LY01005 Project Manager.
Q: Ms. Li, the CMC team you led played a pivotal role in the development of LY01005, can you tell us what you have learned from participating in this project?
Li: LY01005 is the world’s first and only formulation of long-acting goserelin microspheres approved for launch. We encountered a lot of difficulties during the R&D process, and it was the result of the whole team's efforts that we were finally able to get the approval within the challenging time frame. My personal growth was also accompanied by the R&D process of this project, and I have gained even more, especially after I became the head of the CMC.
First of all, I think it is the change of role that has changed my way of thinking, I need to make sure that the sub-items of work are carried out in place and that there is no room for error in terms of progress and quality. Also learn to focus on critical and forward-looking tasks, such as risk identification and response, weighing factors and participating in decision-making. Second, I have realized the importance of professional competencies to R & D. We submitted the application in December 2012, in order to prepare CRL response to CDE as soon as possible. Ms. Zhang Xuemei, head of the project suggested all department to prepare feedback based on possible questions proposed by CDE, and conduct supplementary studies. This work has proved to be very meaningful, for example, we have prepared in advance some key intermediate product research, material loss research and impurity correspondence research, these issues were addressed by CDE experts during review process, and we were fully prepared since we made the correct prediction. We felt nervous and excited, just like betting on the right questions in your most important exam. I think it is the team's technical expertise that allows us to make forward-looking and accurate judgments, so that we can always be prepared and targeted during the R & D process. Also team work is very important, one person can go fast, but a group of people can go farther. In the later stage of the review, each member of the R&D, production and registration team performed their duties and finally reached the smooth progress of the approval.
Members of the LY01005 project team
Q: Mr. Yu, you’ve mentioned this is your first time to lead non-clinical work in a project. Have you met any challenges?
Yu: I had just graduated when I took over this program, and I can say that my personal growth from a student to a new drug researcher was accomplished through LY01005, so I am very grateful for this program. I have faced a number of challenges over the years. I was entrusted with an important task shortly after I graduated from school, with a lot of pressure and a lack of confidence. Dr. Tian and Dr. Ye helped me a lot during that time by coaching me. I was able to learn and understand relative regulations and guidance principles in a short period of time, sorted out the research projects that need to be completed for the non-clinical filing of new drugs, summarized the filing information of marketed drugs with similar mechanisms, therefore strengthened my confidence to handle the project.
Non-clinical team
Q: Mr. Liu, as the head of clinical, what are the differences of LY01005 compared with other projects that you have participated.
Liu: Compared to other projects I have worked on before, LY01005 is different and difficult in several ways: 1. Patient enrollment is very challenging for this project, considering it requires new patients. However, new patients are normally discovered in outpatient or surgical inpatient department and immediately receive medication treatment once discovered. Therefore, it has posed a big challenge to us. 2. This project requires large number of biological sample collection; we have to strictly follow collection time window and the program. During this period, we were also disturbed by the recurring outbreaks, for which we and the doctors thought of a lot of ways to do a complete evaluation of various alternative solutions, and finally successfully completed all the clinical studies.
Clinical team
Q: What is the significance of the approval of LY01005 for this project?
Peng: In fact, while everyone was working towards the June 30th approval, it wasn't until the last minute when we heard the news of the approval that the hanging hearts were finally put at ease. Sometimes there are things that you may find difficult, but it is necessary for you to insist a little more, "where there is a will, there is a way" is a cliché, but it is unbreakable.
December 2021, Registration team preparing NDA files for LY01005
Q: As the project manager of LY01005, what do you think are the important factors to ensure that all departments work efficiently with each other to successfully reach the final goal?
Geng: The success of this project cannot leave without the joint efforts of all team members and support of Group leaders. Regarding efficient collaboration among all departments, I think there are several points: First, we need to have clear targets and plans, clarify the overall objectives from the Group level, identify key milestones, and then communicate the information with all teammates. So that everyone can be clear with their own tasks and responsibilities and work together to achieve the final target. Second, good communication can play a coordinating role, and the PM needs to build a bridge of communication to coordinate the project members as well as the resources of all parties to jointly solve the problems encountered in the process. Third, all departments within the project are connected. Usually I use WeChat to keep frequent communication with them or organize team meetings if needed, just to ensure everyone can get an update on the project in time. Finally, is the incentive mechanism, it is always important to keep the team united considering drug development is a long-term process. When completing key milestones, we will organize team building activities or distribute small gifts, which will also help to boost everyone's motivation.
Group photo of LY01005 project team at the internal celebration for its successful approval
Q: Last but not least, please share your expectations of this project in the coming year.
Geng: LY01005 is the first and only formulation of long-acting goserelin microspheres approved for launch in China. It is also Luye Pharma’s second approved microsphere product, which again proved our technology capabilities. I believe with the joint collaboration between Luye and BeiGene can benefit more patients. We are also looking forward to the early approval of the second indication of the product to bring hope to more patients. We are confident about the bright future of this product.
Yu: I have been with this project from the beginning to approval, so I have a deep feeling for it. When we did the non-clinical evaluation, the animal studies showed that our product was more durable and stable in suppressing testosterone levels than the original product, so we also hope that this advantage can be truly translated into clinical for the benefit of more patients. At the same time, we also hope that the subsequent projects on the Group's innovative preparation platform can go smoother and smoother, and that the innovative preparations independently researched and developed by our local enterprises can bring more clinical advantages and market value.
Li: Before June 30th of this year, AstraZeneca's Noladex implant was the only Goserelin product on the market in China, but now Baituowei has joined the competition, and we have upgraded Goserelin to a microsphere dosage form and improved the injection method, which I believe will bring positive changes to the overall clinical treatment landscape. With subsequent approvals for other indications, Baituowei will benefit more patients. This project truly puts into practice what Chairman Liu emphasized, that Luye Pharma is a company committed to working tirelessly to improve clinical benefits for patients through providing differentiated and innovative products with clinical value. We are confident in the future of Baituowei.
Liu: This product is a presentation of Luye Pharma’s mission— “Advanced technologies for better quality of life”. We have broken the dominant market situation of the original drug. The approval of Baituowei is not the end, we will continue to make this product better and better through continuous improvement and achieve its commercial success.
Peng: The first batch of Baituowei is already delivered to the market. We feel that our work is valuable and meaningful. We are also expecting the approval of its second indication, so the market potential is tremendous. The successful approval of LY01005 is an important milestone for R&D. In the future, there are several other projects in the process of filing for NDA. We are looking forward to see more blockbuster products to be approved next year. We will continue to work together and support Luye to enter into the next 30 years.
